Pediatric ALLNCT05565040
Concealed Penis in Pediatric Age Group
A study testing Circumcision in concealed penis in people with Pediatric ALL and Surgery, run by Egyptian Biomedical Research Network at 1 site in Egypt.
Trial summary
Background: Comparison between three different surgical techniques in the management of concealed penis. Methods: This prospective interventional non-randomized study included 150 pediatric patients with concealed penis. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Pediatric ALL, Surgery, Urologic Diseases
- What is being tested?
- Circumcision in concealed penis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2018to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with a buried penis at or below the pubic skin level with a stretched penile length for all of them within the normal range according to their ages as titrated in the literature
Who cannot join
- Patients with any associated anomalies like hypospadias, torsion, penoscrotal web, micropenis, mega-prepuce, or chordae were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concealed Penis in Pediatric Age Group; A Comparison Between Three Surgical Techniques
Background: Comparison between three different surgical techniques in the management of concealed penis. Methods: This prospective interventional non-randomized study included 150 pediatric patients with concealed penis. They were distributed equally into three groups; group A; patients treated by phallopexy only, group B; patients treated by complete dissection and excision of dartos fascia \& group C; patients treated by both phallopexy and dartos excision.
Read the detailed description
Background: Comparison between three different surgical techniques in the management of concealed penis. Methods: This prospective interventional non-randomized study included 150 pediatric patients with concealed penis. They were distributed equally into three groups; group A; patients treated by anchoring the penile skin dermis to Buck's fascia at the penile base at 3 \& 9 o'clock points using PDS 5/0 (phallopexy), group B; patients treated by complete dissection and excision of dartos fascia \& group C; patients treated by phallopexy as in group A after complete dissection and excision of dartos fascia. Follow-up at the end of the 1st post-operative week and then monthly for 6 months as regards penile skin congestion and/or necrosis, wound infection, edema, and/or re-retraction was carried out.
- Conditions
- Pediatric ALL, Surgery, Urologic Diseases
- Being tested
- Circumcision in concealed penis
- Keywords
- Concealed, phallopexy, dartos excision, degloving, penile re-retraction
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Urologic Diseases, Degloving Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circumcision in concealed penisProcedure or surgery
comparison of three surgical techniques (as described in the arms) in the management of concealed penis in pediatrics
| Study group | Role | What they receive |
|---|---|---|
| Phallopexy group | Experimental | phallopexy only Receives: Procedure: Circumcision in concealed penis |
| Dartos excision group | Experimental | complete circumferential dissection and excision of dartos fascia only Receives: Procedure: Circumcision in concealed penis |
| Combined phallopexy and dartos excision group | Experimental | phallopexy as in patients of group A but after complete dissection and excision of dartos fascia Receives: Procedure: Circumcision in concealed penis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative appearance of penile skin congestion and/or necrosis
Repeated and regular monthly examination of the patients as regards persistent bluish penile discoloration and or loss of penile skin viability. Also a questionnaire of parents about penile skin color, loss of skin, and/or appearance of any abnormal tissues
Measured: 6 months
Wound infection
Repeated and regular monthly examination of the patients as regards the appearance of any penile skin infection and/or pyogenic discharge. Also a questionnaire of parents about the appearance of penile skin redness, pyogenic discharge, and/or the appearance of any pyogenic membranes
Measured: 6 months
Penile edema
Repeated and regular monthly examination of the patients as regards the appearance of penile skin edema. Also a questionnaire of parents about any increase of penile girth than the usual
Measured: 6 months
Penile re-retraction
Repeated and regular monthly examination of the patients as regards the development of any penile re-retraction in the form of retraction of the penis to or beneath the level of pubic skin. Also, a questionnaire of parents about this finding was done
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start1 Jun 2018
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric ALLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egyptian Biomedical Research Network
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Ahmed Elrouby, Egyptian Biomedical Research Network
- Investigators
- Ahmed EZ Elrouby, A.Professor, Principal investigator, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565040
- Sponsor's protocol ID
- 0305434
- Status last verified
- Oct 2022
- First submitted
- 21 Sep 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elrouby A. Concealed penis in pediatric age group: a comparison between three surgical techniques. BMC Urol. 2023 Jan 11;23(1):9. doi: 10.1186/s12894-022-01169-3.
PubMed 36631822
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concealed Penis in Pediatric Age Group; A Comparison Between Three Surgical Techniques
- ClinicalTrials.gov ID
- NCT05565040
- Acronym / sponsor ID
- 0305434
- Conditions
- Pediatric ALL, Surgery, Urologic Diseases
- Keywords
- Concealed, phallopexy, dartos excision, degloving, penile re-retraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Egyptian Biomedical Research NetworkResearch network
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Comparison between three different surgical techniques in the management of concealed penis. Methods: This prospective interventional non-randomized study included 150 pediatric patients with concealed penis. They were distributed equally into three groups; group A; patients treated by phallopexy only, group B; patients treated by complete dissection and excision of dartos fascia \& group C; patients treated by both phallopexy and dartos excision.
Detailed description
Background: Comparison between three different surgical techniques in the management of concealed penis. Methods: This prospective interventional non-randomized study included 150 pediatric patients with concealed penis. They were distributed equally into three groups; group A; patients treated by anchoring the penile skin dermis to Buck's fascia at the penile base at 3 \& 9 o'clock points using PDS 5/0 (phallopexy), group B; patients treated by complete dissection and excision of dartos fascia \& group C; patients treated by phallopexy as in group A after complete dissection and excision of dartos fascia. Follow-up at the end of the 1st post-operative week and then monthly for 6 months as regards penile skin congestion and/or necrosis, wound infection, edema, and/or re-retraction was carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phallopexy group | Experimental | Procedure: Circumcision in concealed penisphallopexy only |
| Dartos excision group | Experimental | Procedure: Circumcision in concealed peniscomplete circumferential dissection and excision of dartos fascia only |
| Combined phallopexy and dartos excision group | Experimental | Procedure: Circumcision in concealed penisphallopexy as in patients of group A but after complete dissection and excision of dartos fascia |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with a buried penis at or below the pubic skin level with a stretched penile length for all of them within the normal range according to their ages as titrated in the literature
Key exclusion criteria (1 listed)
- Patients with any associated anomalies like hypospadias, torsion, penoscrotal web, micropenis, mega-prepuce, or chordae were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circumcision in concealed peniscomparison of three surgical techniques (as described in the arms) in the management of concealed penis in pediatrics | Procedure or surgery | Combined phallopexy and dartos excision group, Dartos excision group, Phallopexy group |
Primary outcome
Post-operative appearance of penile skin congestion and/or necrosis
Time frame: 6 months
Repeated and regular monthly examination of the patients as regards persistent bluish penile discoloration and or loss of penile skin viability. Also a questionnaire of parents about penile skin color, loss of skin, and/or appearance of any abnormal tissues
Wound infection
Time frame: 6 months
Repeated and regular monthly examination of the patients as regards the appearance of any penile skin infection and/or pyogenic discharge. Also a questionnaire of parents about the appearance of penile skin redness, pyogenic discharge, and/or the appearance of any pyogenic membranes
Penile edema
Time frame: 6 months
Repeated and regular monthly examination of the patients as regards the appearance of penile skin edema. Also a questionnaire of parents about any increase of penile girth than the usual
Penile re-retraction
Time frame: 6 months
Repeated and regular monthly examination of the patients as regards the development of any penile re-retraction in the form of retraction of the penis to or beneath the level of pubic skin. Also, a questionnaire of parents about this finding was done
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Derived from this study: PubMed 36631822Elrouby A. Concealed penis in pediatric age group: a comparison between three surgical techniques. BMC Urol. 2023 Jan 11;23(1):9. doi: 10.1186/s12894-022-01169-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed EZ Elrouby, A.Professor principal investigator
University of Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circumcision in concealed penis in people with Pediatric ALL and Surgery, run by Egyptian Biomedical Research Network at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative appearance of penile skin congestion and/or necrosis (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05565040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.